New Models for Fostering Innovation in Pharmacovigilance

Life Sciences, Pharmaceutical Regulation, Medical Device, Drug Safety, Medical Device Safety and Regulation, Pharmacovigilance, Patient Safety,
  • Thursday, October 22, 2020

The pharmacovigilance market is undergoing a paradigm shift and technology innovation is at the center of this transformation. During this webinar, subject matter experts discuss the state of the pharmacovigilance industry and a unique technology roadmap approach for operational success. They will also examine different partnership models from the perspective of small, medium and large pharma.

Speakers

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Dinesh Kasthuril, Global Head, Client Relationships & Project Management, Covance

Dinesh Kasthuril is the Global Head of Client Relationships and Project Management at Covance Patient Safety and Adjudication Services. In his current role Dinesh provides strategic leadership to all Pharmacovigilance engagements globally. He is a senior executive in the pharmaceutical R&D domain with over 18 years in safety across Big Pharma, Biotechs, Mid-size Pharma and service providers. Dinesh is educated from Syracuse University and the University of Pennsylvania.

Message Presenter
http://Naveen%20K,%20Covance

Dr. Naveen K.K., Executive Director & Head, Safety Solutions and Centralized Medical Data Review, Covance

Dr. Naveen K.K. is the Executive Director & Head of Safety Solutions and Centralized Medical Data Review at Covance. In his role, he focuses on defining and driving safety technology strategy for current and future needs of the pharmacovigilance practice. Naveen has worked across India, China, Japan and the US as operations head for multiple R&D functions like Centralized Monitoring, Medical Data Review, Pharmacovigilance and Connected Devices in CRO & ITES companies. He holds a Bachelor’s degree in Medicine, a Bachelor’s degree in Surgery, and a Master’s in Business Administration specializing in Global Business Management and Information Systems.

Message Presenter
http://Lora%20Blackowicz,%20Tersera%20Therapeutics

Lora Blackowicz, ‎Vice President, Pharmacovigilance, TerSera Therapeutics

Lora Blackowicz is Vice President of Pharmacovigilance at TerSera Therapeutics. She has over 25 years of experience in pharmacovigilance in leadership roles at Takeda Pharmaceuticals and TAP Pharmaceuticals. Lora holds a PharmD from the University of Florida, a BS in Pharmacy from the University of Illinois Chicago and an MBA from Lake Forest Graduate School of Management.

Message Presenter
http://William%20Snyder,%20Amgen

William Snyder, Director, Supplier Performance Management, Research & Development Strategy and Operations, Amgen

William Snyder is Director, Supplier Performance Management, Research & Development Strategy and Operations at Amgen. Prior to joining Amgen he was Director of New York Platform Lead Records Management at Pfizer. He has over 35 years of experience in the healthcare industry across pharmaceuticals, biotechnology, clinical diagnostics, and enterprise systems (Documentum, Oracle & SAP) and includes working internationally in EU, India, and Japan. This diversity of experience has allowed him to develop diverse skills and a broad set of competencies that include information and document management, IT, system deployments, supplier management, strategic outsourcing, clinical instrumentation development, process management, and marketing. Bill holds a BS in Information Technology from the University of Phoenix,  a BS in Medical Technology and an MS in Health Science from Stony Brook University.

Message Presenter
http://Nirmal%20Patel,%20Jannsen%20Inc.

Nirmal Patel, Director, Global Medical Safety Operations Innovation, Janssen Inc.

Nirmal Patel is Director, Global Medical Safety Operations Innovation at Janssen. He has over 20 years of experience in the life sciences industry and has held leadership roles in the pharmacovigilance operations and biotechnology domains. Prior to joining Janssen, he was in the consumer sector at Johnson and Johnson and has lead other biotech startup companies. Nirmal holds a BS in Information Technology and an MBA from the LeBow College of Business at Drexel University.

Message Presenter

Who Should Attend?

  • AD/Directors/Senior Directors/Heads of Safety, Pharmacovigilance or Device Vigilance
  • AD/Directors/Senior Directors/Heads of Regulatory
  • AD/Directors/Senior Directors/Heads of Technology
  • Heads of Procurement

What You Will Learn

Participants will learn:

  • Challenges and approaches on how technology can be used and implemented in various settings and to move towards real-time pharmacovigilance
  • How to overcome these challenges via best practices
  • Pros and cons of various client-vendor partnership models

 

 

 

Xtalks Partner

Covance

Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives.

Covance is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical, and regulatory expertise. We generate more safety and efficacy data to support drug approvals than any other company, supporting our clients’ complete lifecycle management.

Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Visit us at www.covance.com.

Covance Patient Safety Solutions offers comprehensive global clinical trial and post-marketing drug and device vigilance capabilities, including medical call center, case processing, medical review, aggregate reporting, and signal detection and risk management. Our unique combination of best-in-class domain expertise, technology platforms and automation tools, delivered in a flexible and tailored approach accelerates business, drives higher levels of performance and fosters innovation. Our passion for scientific and therapeutic area excellence facilitates the delivery of safe and effective drug and device therapies. Learn more about our commitment to patient care, scientific rigor, quality, compliance, scalability, customized & tailored solutions, innovation, process maturity and proven track record by visiting www.covance.com/patient-safety or email us at marketaccess@covance.com.

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